Questionnaire ISO 13485

During the implementation of a quality system, and in the preparation for an audit, it makes sense to use a questionnaire to ascertain whether all topics from the standard are covered. We have drawn up a questionnaire for our own use. This questionnaire is updated and improved over many years of practical use. In over 300 questions the entire ISO 13485: 2003 standard is assessed.
 
A free evaluation version is available to give you an impression on the design and content of this questionnaire.
 
This free version covers the following standard paragraphs:
 
4.1
General requirements

4.2.2 Quality manual
5.3 Quality policy
6.2.2 Competence, awareness and training
6.3 Infrastructure
7.4.1 Purchase process
A full questionnaire can be ordered by using our order form.